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Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

Phase 3
18 Years
60 Years
Open (Enrolling)

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Trial Information

Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

For many years, allogeneic bone marrow transplantation has been used to successfully treat
leukemias, other hematologic conditions and congenital disorders. The first unrelated donor
transplants were performed in the late 1970s, but this procedure did not become widely
available until the development of several consolidated unrelated donor registries around
the world. The National Marrow Donor Program, established in 1987, is the world's largest
registry and currently lists more than 7 million donors. Since its beginning, NMDP has
facilitated more than 30,000 unrelated transplants.

Although not a licensed indication, considerable experience has been accumulated concerning
administration of filgrastim to normal adults. Most of these adults were volunteer research
subjects or donors of PBSC for use in related donor transplants. Beginning in February 1997,
filgrastim stimulated PBSC have been collected from NMDP donors under protocol. The protocol
(locally referred to as G2) began under an NMDP-sponsored Investigational New Drug (IND)
application filed with FDA for collecting PBSC for a second donation following an initial
donation of bone marrow. In 1999 a second protocol was opened (locally referred to as G1) as
requests for PBSC as a primary donation source became more common. In 2005 the two protocols
were combined to eliminate redundancy and provide for ease of use.

The protocol establishes and evaluates a system to supply peripheral blood stem cell (PBSC)
products for use in unrelated donor hematopoietic stem cell (HSC) transplantation. The
protocol describes processes for donor identification, education and evaluation. Procedures
for administration and monitoring of the stem cell mobilizing agent filgrastim are included.
The protocol also describes procedures for the collection of PBSC products by leukapheresis
and includes provisions for long term donor follow-up.

Inclusion Criteria:

- PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set
forth in NMDP Standards and the Donor Center Manual of Operations.

Exclusion Criteria:

- Pregnancy or uninterruptible breastfeeding. Pregnancy is an absolute contraindication
under this protocol. Women who are breastfeeding must be willing and able to
interrupt breastfeeding during the administration of filgrastim and for two days
following the final dose.

- Sensitivity to filgrastim or to E. coli-derived recombinant protein products.

- History of autoimmune disorders, including rheumatic diseases and thyroid disorders.
Exception: As with bone marrow donations, donors with a history of thyroid disease
who have undergone successful therapy may be suitable.

- History of deep vein thrombosis or pulmonary embolism.

- History of iritis or episcleritis.

- Thrombocytopenia < 150 x 10(9)/L (< 150,000/µL) at baseline evaluation.

- Current treatment with lithium. Drug interactions between filgrastim and lithium,
which may potentiate the release of neutrophils, have not been fully evaluated.

- Positive Hemoglobin-Solubility (e.g., SickleDex™ or equivalent) test.

- Donors receiving experimental therapy or investigational agents.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from NMDP donors.

Outcome Time Frame:


Safety Issue:


Principal Investigator

John P Miller, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Marrow Donor Program


United States: Food and Drug Administration

Study ID:




Start Date:

February 1997

Completion Date:

January 2022

Related Keywords:

  • Healthy
  • Healthy Unrelated Stem Cell Donors



James Graham Brown Cancer Center Louisville, Kentucky  40202
City of Hope National Medical Center Los Angeles, California  91010
Baylor University Medical Center Dallas, Texas  75246
New York Blood Center New York, New York  10021
Cook Children's Medical Center Fort Worth, Texas  76104
Puget Sound Blood Center Seattle, Washington  98014
Michigan Community Blood Centers Grand Rapids, Michigan  49503
NMDP at Northern California & Northwest District Oakland, California  94612
Blood Bank of San Bernardino & Riverside Cts. San Bernadino, California  92408
San Diego Blood Bank San Diego, California  92103
NMDP Southern California & Southwest District Santa Ana, California  92705
Colorado Marrow Donor Program Denver, Colorado  80230
NMDP Northeast District - New England Office West Hartford, Connecticut  06110
NMDP Southeast District - Washington D.C. Office Washington D.C., District of Columbia  20004
Gift of Life Bone Marrow Foundation Boca Raton, Florida  33431
LifeSouth Community Blood Centers Gainesville, Florida  32607
Community Blood Centers of So. Florida, Inc. Lauderhill, Florida  33313
Florida's Blood Centers, Inc. Orlando, Florida  32809
Florida Blood Services, Inc. St. Petersburg, Florida  33716
Hawaii Bone Marrow Donor Registry Honolulu, Hawaii  96817
LifeSource Glenview, Illinois  60025
Rock River Valley Blood Center Rockford, Illinois  61107
Community Blood Services of Illinois Urbana, Illinois  61801
Indiana Blood Center Indianapolis, Indiana  46208
Iowa Marrow Donor Program Iowa City, Iowa  52242
NMDP Southcentral District, Heart of America Donor Center Leawood, Kansas  66206
NIH Marrow Donor Center Rockville, Maryland  20892
C.W. Bill Young Marrow Donor Center Rockville, Maryland  20852
Dana Farber/Partners Cancer Care Boston, Massachusetts  02115
The Caitlin Raymond International Registry Worcester, Massachusetts  01655
NMDP Northcentral District - Michigan Office East Lansing, Michigan  48823
NMDP Northcentral District - Minnesota Office Minneapolis, Minnesota  55413
Mississippi Marrow Donor Program Jackson, Mississippi  39216
The HLA Registry Oradell, New Jersey  07649
DKMS Americas New York, New York  10016
NMDP Northeast District - Greater NY State Office Rochester, New York  14607
NMDP Southeast District Charlotte, North Carolina  28269
NMDP Northcentral District Cleveland, Ohio  44131
Community Blood Center Dayton, Ohio  45402
Sylvan N. Goldman Center, Oklahoma Blood Institute Oklahoma City, Oklahoma  73104
NMDP Northern California & Northwest District - Oregon Office Portland, Oregon  97210
NMDP Northeast District Philadelphia, Pennsylvania  19123
Central Blood Bank Pittsburgh, Pennsylvania  15220
Rhode Island Blood Center Providence, Rhode Island  02908
Blood Assurance, Inc. Chattanooga, Tennessee  37403
Cooperative Appalachian Marrow Program Johnson City, Tennessee  37604
Carter BloodCare Bedford, Texas  76021
Gulf Coast Regional Blood Center Houston, Texas  77054
South Texas Blood and Tissue Center San Antonio, Texas  78201
Scott & White Clinic Temple, Texas  76508
NMDP Southeast District - Virginia Office Richmond, Virginia  23229
Inland Northwest Blood Center Spokane, Washington  99201
Community Blood Center, Inc. Appleton, Wisconsin  54914
The Blood Center of Wisconsin Milwaukee, Wisconsin  53233